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NCT Number: NCT05871164

Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency

The purpose of the study is to evaluate the oncological efficacy of pancreatic radiofrequency by the objective response rate (complete and partial responses according to RECIST 1.1.), 5 years after the end of treatment.

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Key information

Conditions

Pancreatic Tumor Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHI Toulon La Seyne

Toulon, 83056, France

Location status: Recruiting

Location contact

Philippe AH-SOUNE, MD

CONTACT

[email protected]

About this study

This is a prospective, longitudinal, open, non-randomized, non-interventional, multicenter study on ultrasound-guided radiofrequency endoscopy for the treatment of pancreatic tumours. The study will be offered prospectively to all patients in need of treatment. They will be taken care of in accordance with current practice.

The patient will be seen again 7 times after the end of the pancreatic radiofrequency (which will include one or two sessions): the follow-ups will be done according to current practice on D15 ± 7 days, M6 ± 14 days, M12 ± 1 month then annually until M60 ± 1 month.

The study consists to evaluate the oncological efficacy at 5 years of pancreatic radiofrequency delivered by means of a needle guided by ultrasound endoscopy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old;
  • Patient to be treated for a pancreatic tumor by ultrasound-guided RF with a fine needle;
  • Indication of pancreatic radiofrequency validated in a Multidisciplinary Consultation Meeting;
  • Patient able to understand the information related to the study;
  • Patient accepting study follow-up visits;
  • Patient having been informed and agreeing to participate in the study.

Exclusion criteria

  • Patient with a contraindication to radiofrequency treatment;
  • Pregnant or breastfeeding women

Treatment and study plan

Pancreatic radiofrequency

Procedure

Pancreatic radiofrequency is similar to a puncture under echoendoscopy. The lesion is located then punctured by transgastric or transduodenal route either using a 19 gauge needle with exchange of the stylet for a probe, or using a 19 gauge needle whose distal end of 5-10 mm corresponds to the active part, connected to a generator with an integrated cooling system.

Primary outcomes

  1. Carcinological efficacy of pancreatic radiofrequency

    Time frame: 5 years

    The primary endpoint of the study is the oncological efficacy of pancreatic radiofrequency, which will be assessed by the objective response rate (complete and partial responses according to RECIST 1.1.), 5 years after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Bertrand NAPOLEON, MD

CONTACT

[email protected]

428636969 ext. +33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Acronym: RAFPAN2

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
May 23, 2023
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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